Ocean Pier, Inc. 11/21/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
November 21, 2012
VIA EXPRESS DELIVERY
Mr. Mike Breau
Ocean Pier, Inc.
20 Pattison Street
Scoudouc, New Brunswick
Canada E4P 3R4
Reference No. 370338
Dear Mr. Breau:
On June 25, 2012 and June 26, 2012, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 20 Pattison Street, Scoudouc, New Brunswick, Canada E4P 3R4. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We received your firm’s response to the FDA-483 on August 7, 2012. Our review of the documentation revealed that the response was not adequate, as further described in this letter.
In accordance with Title 21, Code of Federal Regulations, Section 123.6(g) [21 CFR 123.6(g)], failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your frozen vacuum packaged crab cakes and vacuum packaged crab Rangoon are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation and the 4th
Edition of the Fish and Fisheries Products Hazard and Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.FDA.gov
. The 4th
Edition of the Hazards Guide can be found on our web site at:
We have reviewed the revised HACCP plans provided in your response and note the following deviations:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s revised HACCP plans are not adequate, as follows:
- Your HACCP plan for Non Fried Crab Cakes does not list the following food safety hazards:
• undeclared allergens.
FDA recommends that firms conduct a label review for each batch of labels comparing the ingredient statements with the product formulations to ensure all allergenic substances are accurately declared.
• Staphylococcus aureus growth and toxin formation during processing/handling
FDA recommends that for firms conducting significant handling of products such as cakes that include breading ingredients, firms control the exposure time to less than three hours when exposed to temperatures above 70° F.
• Clostridium botulinum growth and toxin formation in the finished packaged product.
With regard to Clostridium botulinum in frozen products packaged in oxygen impermeable materials, FDA recommends that firms conduct a label review of each batch of labels to ensure that the labels include the handling instructions to “Keep Frozen, Thaw Under Refrigeration Immediately Before Use.”
- Your revised HACCP plan for (crab) Rangoon does not list the food safety hazard of undeclared allergens.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s revised HACCP plan for Non Fried Crab Cakes does not list a critical limit at the “Step #6: (b)(4)” critical control point to control growth of pathogens.
Specifically, your plan fails to list a critical limit for the ambient thawing temperature of the cooler. FDA recommends the following:
- Maintain ambient temperatures for thawing frozen pasteurized crabmeat below 40°F (4.4°C)
- Use a continuous temperature data logger for monitoring refrigerated cooler storage
- Check the recorded temperatures daily to ensure that proper temperatures have been maintained
- Check the monitoring equipment itself daily to ensure that it is operating properly.
3. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for (crab) Rangoon does not list the following critical control points:
- (b)(4) pasteurized crab meat to control the identified hazard of pathogens.
- Cooking to control the identified hazard of Listeria monocytogenes. FDA recommends that firms include cooking process controls based on a scientific study that consistently achieves a 6 log reduction (6D) under worst case conditions (i.e., coldest initial temperature of the largest piece of product located in the coldest part of the cooking unit, largest batch load.)
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for Rangoon lists a monitoring procedure at the “Step #14 & Step #17” critical control point (cooling after the cook) that is not adequate to control pathogen growth. Your plan includes a critical limit of (b)(4) however, your monitoring procedure does not list that your firm will measure product temperature to ensure that the critical limits will be met.
5. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for your firm’s revised HACCP plan for Non Fried Crab Cakes at the “Step #6: (b)(4)” critical control point and your firm’s revised HACCP plan for Rangoon at the “Step #14 & Step #17” critical control point (cooling after the cook) are not adequate.
Your plans list that when temperature critical limits are exceeded, the product will be placed on hold immediately and samples of product will be sent for microbiological analysis for pathogens. The subsequent release of the product will be pending the laboratory results. FDA does not consider random testing of products adequate to determine the safety of an entire lot of product when that lot has been exposed to potentially unsafe conditions. FDA recommends evaluating the time and temperature deviations and determining the impact of the deviations on the product.
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/ialist.html
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility.
The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. You should consider providing your U.S. Agent with a copy of this letter.
Please send your reply to the Food and Drug Administration, Attention: Stuart A. Feldman, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Feldman by phone at (240) 402-3006 or via email at firstname.lastname@example.org
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition